The Voice as a Tool to Detect Recurrence of Laryngeal and Hypopharyngeal Cancer

Официальное название

The Voice as a Tool to Detect Recurrence of Laryngeal and Hypopharyngeal Cancer (VoiceDetect) - a Feasibility Study

Обзор

The investigators will obtain three-monthly voice recordings and fiberendoscopic examinations of the larynx/hypopharynx for a minimal period of 6 months from all laryngeal/hypopharyngeal squamous cell carcinoma (LSCC/HPSCC) patients, who have successfully completed curative primary treatment, except those who underwent total laryngectomy. Furthermore, the investigators will ask the patients to fill out the voice handicap index-30 questionnaire (VHI-30) during each study visit. The VHI-30 allows to make a subjective assessment of the patients' own vocal problem. The primary objective is to assess the feasibility and compliance of longterm regular voice monitoring in LSCC and HPSCC follow-up.

Вмешательства

• Другое Voice recording, ENT (Ear, Nose and Throat) examination including transnasal fiberendoscopy, and VHI-30-questionnaire
  The following speech samples will be recorded from the study participants: * Standardized, phonetically balanced text * Sustained, modulated production of five vowels * Picture description * Diadochokinetic exercise. Before starting speech recording, the participant fills in a questionnaire consisting of: * Health barometer * Self-rating in terms of stress/fatigue/emotional status. An Ear, Nose and Throat examination incl. transnasal fiberendoscopy is performed at each visit. The investigato

Первичные конечные точки

• Patients' compliance with scheduled 3-monthly endoscopic exam, voice recordings, and filling out of questionnaire [Срок оценки: 3-21 months]
• Recruitment rate [Срок оценки: 0-21 months]

Вторичные конечные точки (10)

• Subjective changes in voice [Срок оценки: 0-21 months]
• Objective changes in voice 1 [Срок оценки: 0-21 months]
• Objective changes in voice 2 [Срок оценки: 0-21 months]
• Objective changes in voice 3 [Срок оценки: 0-21 months]
• Objective changes in voice 4 [Срок оценки: 0-21 months]
• Recurrences of the index tumor [Срок оценки: 0-21 months]
• Recurrences in other localizations [Срок оценки: 0-21 months]
• Second primary malignancies in the larynx/hypopharynx [Срок оценки: 0-21 months]
• Second primary malignancies in other localizations [Срок оценки: 0-21 months]
• Composite of clinical events [Срок оценки: 0-21 months]

Критерии участия

Критерии включения

• Histopathologically proven carcinoma in-situ or invasive LSCC or HPSCC (in non-surgically treated carcinoma: clinical/radiologic stage I-IV (excluding M1) according to the Union for International Cancer Control (UICC) / Tumor (T), Nodes (N), and Metastases (M) (TNM) 8th ed.; in surgically treated carcinoma: pathological stage I-IV (excluding M1) according to the UICC / TNM 8th ed.).
• ≥ 18 years of age.
• Treatment with curative intent, regardless of treatment modality (mono- or multimodal).

Remark: Patients with synchronous (larynx and hypopharynx included) or metachronous (before/after the diagnosis of LSCC/HPSCC) non-laryngeal/-hypopharyngeal malignant non-metastatic tumors, with clinically confirmed complete remission 6 months after treatment and life expectancy of at least 6 months are eligible. Patients with surgically treated Tis-2 N0 M0 squamous cell carcinoma and/or basal cell carcinoma of the skin and/or other surgically treated non-head and neck Tis are eligible, although the treatment was within the 6 months before enrolment.

• Clinical confirmation of complete remission of LSCC or HPSCC through Ear, Nose and Throat (ENT) examination, including fiberendoscopy of the pharynx and larynx, at the time of enrolment, during the period of eligibility (6 to 30 months after treatment).

Remark: Patients with synchronous (larynx and hypopharynx included) or metachronous (before/after the diagnosis of LSCC/HPSCC) non-laryngeal/-hypopharyngeal malignant non-metastatic tumors, with clinically confirmed complete remission 6 months after treatment and life expectancy of at least 6 months are eligible. Patients with surgically treated Tis-2 N0 M0 squamous cell carcinoma and/or basal cell carcinoma of the skin and/or other surgically treated non-head and neck Tis are eligible, although the treatment was within the 6 months before enrolment.

• Informed consent as documented by signature.

Критерии исключения

• Total laryngectomy as primary therapy.
• Any local, regional, and systemic laryngeal or hypopharyngeal cancer persistence/progression, or recurrence before enrolment.

Excepted: Patients with synchronous laryngeal/hypopharyngeal malignant non-metastatic tumors, with clinically confirmed complete remission 6 months after treatment and life expectancy of at least 6 months are eligible.

• Any local, regional, and systemic tumor persistence/progression, or recurrence of synchronous (larynx and hypopharynx included) or metachronous (before/after the diagnosis of LSCC/HPSCC) non-laryngeal/-hypopharyngeal malignant tumors within 6 months before enrolment.

Excepted: Patients with surgically treated progredient or recurrent locally defined Tis-2 N0 M0 squamous cell carcinoma and/or basal cell carcinoma of the skin and/or non-head and neck progredient or recurrent Tis.

• Any previously treated LSCC/HPSCC or treated second primary malignancies of the larynx or hypopharynx before the diagnosis and treatment of the investigated LSCC/HPSCC (= index tumor).
• Presence of any medical, psychological, familial, sociological, or geographical conditions expected to potentially hamper the compliance with the study protocol.
• Inability to follow procedures (e.g., inability to read) or insufficient knowledge of any project language (German and French).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Швейцария · 2 центра

• Department of Oto-Rhino-Laryngology, Head and Neck Surgery, Inselspital, Bern University H — Bern
• Department of Oto-Rhino-Larnygology, Head and Neck Surgery, University Hospital Zurich — Zurich

Идентификаторы

NCT: NCT05894070 · 2023-00838

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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